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Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01066195
First received: February 8, 2010
Last updated: February 9, 2010
Last verified: February 2010
History of Changes
  Purpose

Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (NSCLC) patients with clinical characteristics such as adenocarcinoma, never smoker and female.

The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Drug: iressa
Drug: alimta
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multi-center, Randomized Trial of Pemetrexed and Gefitinib in Never-smoker and Adenocarcinoma Patients With Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • objective response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 129
Study Start Date: May 2008
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gefitinib Drug: iressa
iressa 250mg per day every day
Active Comparator: pemetrexed Drug: alimta
alimta 500mg/m2 every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma
  2. Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer
  3. Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy)
  4. Never smoker (less than 100 cigarette for the life time)
  5. 18 year or older
  6. ECOG 0-2
  7. No history of biologic or immunotherapy
  8. Tolerable renal function ( creatine clearance rate is 60ml/min or more)
  9. Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)

Exclusion Criteria:

  1. symptomatic brain metastasis
  2. previously treated with EGFR tyrosine kinase inhibitor
  3. previously treated with antifolate agents
  4. poor oral absorption
  5. patients with active infection
  6. uncontrolled diabetes mellitus
  7. significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure)
  8. pregnant or nursing patients
  9. history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066195

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Myungju Ahn, Ph.D., M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Myungju Ahn Ph.D., M.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01066195     History of Changes
Other Study ID Numbers: 2008-04-030
Study First Received: February 8, 2010
Last Updated: February 9, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Non-Small Cell Lung Cancer
Never-Smoker and Adenocarcinoma patients
Pemetrexed (ALIMTA)
Gefitinib (IRESSA®)

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Pemetrexed
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 17, 2012